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I'm a seasoned program and project management leader with 25+ years of experience in pharmaceutical R&D and medical device development. I excel at leading and developing project managers, and developing effective, pragmatic project management solutions that improve team and organizational effectiveness. Having led dozens of cross-functional, and geographically dispersed teams on highly complex development projects, my ability to communicate at all levels of the organization, and my attention to detail and disciplined execution is well-suited to many industries.…I'm a seasoned program and project management leader with 25+ years of experience in pharmaceutical R&D and medical device development. I excel at leading and developing project managers, and developing effective, pragmatic project management solutions that improve team and organizational effectiveness. Having led dozens of cross-functional, and geographically dispersed teams on highly complex development projects, my ability to communicate at all levels of the organization, and my attention to detail and disciplined execution is well-suited to many industries.

Jonathan A. Ducarme

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I'm a seasoned program and project management leader with 25+ years of experience in pharmaceutical R&D and medical device development. I excel at leading and developing project managers, and developing effective, pragmatic project management solutions that improve team and organizational effectiveness. Having led dozens of cross-functional, and geographically dispersed teams on highly complex development projects, my ability to communicate at all levels of the organization, and my attention to detail and disciplined execution is well-suited to many industries.…I'm a seasoned program and project management leader with 25+ years of experience in pharmaceutical R&D and medical device development. I excel at leading and developing project managers, and developing effective, pragmatic project management solutions that improve team and organizational effectiveness. Having led dozens of cross-functional, and geographically dispersed teams on highly complex development projects, my ability to communicate at all levels of the organization, and my attention to detail and disciplined execution is well-suited to many industries.

Available to hire

I’m a seasoned program and project management leader with 25+ years of experience in pharmaceutical R&D and medical device development.

I excel at leading and developing project managers, and developing effective, pragmatic project management solutions that improve team and organizational effectiveness.

Having led dozens of cross-functional, and geographically dispersed teams on highly complex development projects, my ability to communicate at all levels of the organization, and my attention to detail and disciplined execution is well-suited to many industries.

Skills

Leadership

Experience Level

Leadership

Expert

Language

English

Fluent

Work Experience

President/Project Management Consultant at Alcomdale Consulting, Inc.

January 1, 2020 - Present

Providing contract project management services to clients. Engaged in 2020–2021 on assignments including: PMA submission development for an in-vitro diagnostic; documentation development for a clinical trial workflow system planned for use in NCI-designated cancer centers; and other life sciences IT initiatives. Led cross-functional teams, developed project plans, tracked milestones, managed risks, and ensured regulator readiness and stakeholder alignment.

Director, Biopharma Program Management, Precision Oncology at Exact Sciences Canada, Ltd.

September 1, 2023 - December 31, 2025

Program management lead for the Resolution Bioscience portfolio of Next-Generation Sequencing (NGS) assays, including post-approval activities for FDA-approved NGS liquid biopsy CDx, PMA submission planning and deficiency responses, alliance management with biopharma partners, feasibility assessments for IUO assays, and leadership of multiple NGS development/validation projects across cross-functional teams.

Director, Resolution Bioscience External Project Management Office at Agilent Technologies Canada, Inc.

January 1, 2021 - December 31, 2023

Led the external PMO responsible for externally facing projects (long-term CDx development agreements, clinical trial collaborations, and RUO testing). Recruited and led a team of Project Managers and Coordinators; managed PMO portfolio status, risks, resources, and external partner relationships; contributed to PMO governance and design reviews for QA/compliance within Resolution Bioscience's QMS.

Associate Director, Diagnostics Program Management Leader at Janssen, Inc.

January 1, 2011 - December 31, 2020

Core member of the Diagnostics Development Team (DxDT), establishing Dx strategy aligned with Compound Development Team objectives. Provided global cross-functional PM leadership, issue resolution, risk management, contingency planning, and fostered a high-performance team culture. Partnered with external diagnostic development collaborators to meet project requirements.

Associate Director, Program Coordination at Janssen Pharmaceutical Research & Development

January 1, 2005 - December 31, 2011

Core PM for multiple compound development projects; planned and managed cross-functional Schedules and resources; performed critical path analysis; supported due diligence for external opportunities; led Capability Management initiatives and standardized scope-change processes.

Associate Manager, Platform Planning at Organon Pharmaceuticals USA, Inc.

January 1, 2002 - December 31, 2005

Managed U.S.-based Platform Planning team for drug development project planning information, resource estimation/allocation, and metrics; ensured global alignment with counterparts; provided leadership to planning coordinators; contributed to Clinical Development workforce planning and standardized processes.

Consultant, Project Manager at BLC Consulting, LLC (Pfizer Global Research & Development)

January 1, 2000 - December 31, 2002

Managed a global Clinical Trial Tracking and Metrics system across North America and Europe; defined study-specific system requirements, supported study setup, rolled out to multiple sites; acted as liaison between end users and software development; delivered operational metrics.

Consultant, Project Manager at Keane, Inc.

January 1, 1998 - December 31, 2000

Worked on Clinical & Regulatory Informatics projects, including labeling tool development, backlog resolution processes for trial sites, and NDA submission data migration.